FDA Medical devices recall ·
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035 recall
- Recall number
- Z-2354-2026
- Date
- (initiated May 1, 2026)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Why was it recalled?
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.
Distribution
US distribution to California.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2354-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.